Clinical Investigation Across the Lifespan

The NICHD intramural clinical research program currently includes 108 protocols with five main areas of focus: (i) adult, pediatric, and reproductive endocrinology; (ii) human genetics; (iii) normal growth and development; (iv) national/international public health; and (v) women's health. The protocols are conducted by 38 NICHD principal investigators and include natural history studies, teaching protocols, and therapeutic trials (Figure 1). In 2011, NICHD clinical protocols contributed to 180 manuscripts and over 100 meeting abstracts.

The conduct of studies is guided by two entities administered by the Office of the Clinical Director: the NICHD Institutional Review Board (IRB) and the NICHD Data Safety Monitoring Committee (DSMC). The NICHD IRB is chaired by Gilman Grave and has 15 members. The composition of the NICHD IRB is diverse, both in terms of medical and ethical expertise and affiliation. New IRB members have widened the board's expertise in reproductive endocrinology, genetics, and the ethics of human subject research. The NICHD IRB supports the National Children's Study. The NICHD DSMC is chaired by Frank Pucino and has five other members. Both committees possess expertise in issues related to clinical trials, ethics, pediatrics, genetics, and reproductive medicine.